Trial · NCT04533737
Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab
NCT04533737, Phase 4, Terminated, LEO Pharma; results first posted 2024-01-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab. Trials, record NCT04533737. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04533737
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab
- NCT number
- NCT04533737
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 113 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Plaque Psoriasis, Psoriasis Vulgaris, Psoriasis
- Interventions
- Brodalumab, Placebo, Guselkumab
- First posted
- 2020-09-01
- Last updated
- 2025-03-14
- Other registries' IDs
- eudract:2019-004099-20
- Results first posted
- 2024-01-09
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Having Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 | Week 16 | Having 100% improvement from baseline in PASI score. The outcome measure is summarized using the least squares mean percentage of subjects having PASI 100 response at Week 16, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition. |
| Secondary | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | up to 28 weeks | Time to having 100% improvement from baseline in PASI score. The outcome measure summarizes the cumulative percentage of subjects with PASI 100 response (stratified by weight) over time, based on the Aalen-Johansen estimator. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition. |
| Secondary | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | up to 28 weeks | Time to having 90% improvement from baseline in PASI score. The outcome measure summarizes the cumulative percentage of subjects with PASI 90 response (stratified by weight) over time, based on the Aalen-Johansen estimator. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition. |
| Secondary | Having PASI 100 Response, Assessed Separately at Weeks 4, 8, and 28. | Weeks 4, 8, and 28 | Having 100% improvement from baseline in PASI score. The outcome measure is summarized using the least squares mean percentage of subjects having PASI 100 response at Weeks 4, 8, and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition. |
| Secondary | Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. | Weeks 4, 8, 16, and 28 | Having 90% improvement from baseline in PASI score. The outcome measure is summarized using the least squares mean percentage of subjects having PASI 90 response at Weeks 4, 8, 16, and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition. |
| Secondary | Having Investigator's Global Assessment (IGA) of 0, Assessed Separately at Weeks 16 and 28. | Weeks 16 and 28 | Having a score of 0 (clear) in IGA. The outcome measure is summarized using the least squares mean percentage of subjects having an IGA score of 0 at Weeks 16 and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline IGA score. The IGA is an instrument used in clinical trials to rate the severity of psoriasis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| Secondary | Having IGA of 0 or 1, Assessed Separately at Weeks 16 and 28. | Weeks 16 and 28 | Having a score of 0 (clear) or 1 (almost clear) in IGA. The outcome measure is summarized using the least squares mean percentage of subjects having an IGA score of 0 or 1 at Weeks 16 and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline IGA score. The IGA is an instrument used in clinical trials to rate the severity of psoriasis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| Secondary | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Weeks 4, 8, 12, 16, 20, 24, and 28 | The outcome measure is summarized using the least squares mean percentage of subjects having a DLQI score of 0 or 1 at Weeks 4, 8, 12, 16, 20, 24, and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline DLQI score. The DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all/not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life. |
| Secondary | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Weeks 4, 8, 16, and 28 | The SF-36v2 is a 36-item general health status assessment. Participants answer each question by selecting 1 of 3 to 6 categorical response options. The SF-36v2 yields scores for 8 health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) and 2 psychometrically derived summary scores (a physical component summary and a mental component summary). The physical component summary score ranges from 5.1 to 79.7. Higher scores indicate better outcome. |
| Secondary | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Weeks 4, 8, 16, and 28 | The SF-36v2 is a 36-item general health status assessment. Participants answer each question by selecting 1 of 3 to 6 categorical response options. The SF-36v2 yields scores for 8 health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) and 2 psychometrically derived summary scores (a physical component summary and a mental component summary). The mental component summary score ranges from -4.0 to 79.7. Higher scores indicate better outcome. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Having Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 | Week 16 | FAS | percentage of subjects | LEAST_SQUARES_MEAN |
| SECONDARY | Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | up to 28 weeks | FAS | percentage of subjects | NUMBER |
| SECONDARY | Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) | up to 28 weeks | FAS | percentage of subjects | NUMBER |
| SECONDARY | Having PASI 100 Response, Assessed Separately at Weeks 4, 8, and 28. | Weeks 4, 8, and 28 | FAS | percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. | Weeks 4, 8, 16, and 28 | FAS | percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Having Investigator's Global Assessment (IGA) of 0, Assessed Separately at Weeks 16 and 28. | Weeks 16 and 28 | FAS | percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Having IGA of 0 or 1, Assessed Separately at Weeks 16 and 28. | Weeks 16 and 28 | FAS | percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. | Weeks 4, 8, 12, 16, 20, 24, and 28 | FAS | percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Weeks 4, 8, 16, and 28 | FAS | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. | Weeks 4, 8, 16, and 28 | FAS | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group176
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Having Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 | Arm 1 (Brodalumab + Dummy 1) | 53.4 | 95% Confidence Interval 40.0 to 66.8 | percentage of subjects | |
| Having Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 | Arm 2 (Guselkumab + Dummy 2) | 35.9 | 95% Confidence Interval 23.0 to 48.7 | percentage of subjects | |
| Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | Arm 1 (Brodalumab + Dummy 1) | <=100 kg Week 1 | 0 | 95% Confidence Interval 0 to 0 | percentage of subjects |
| Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | Arm 2 (Guselkumab + Dummy 2) | <=100 kg Week 1 | 0 | 95% Confidence Interval 0 to 0 | percentage of subjects |
| Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | Arm 1 (Brodalumab + Dummy 1) | <=100 kg Week 2 | 4.5 | 95% Confidence Interval 0.8 to 13.7 | percentage of subjects |
| Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | Arm 2 (Guselkumab + Dummy 2) | <=100 kg Week 2 | 0 | 95% Confidence Interval 0 to 0 | percentage of subjects |
| Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | Arm 1 (Brodalumab + Dummy 1) | <=100 kg Week 4 | 22.7 | 95% Confidence Interval 11.7 to 36.0 | percentage of subjects |
| Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | Arm 2 (Guselkumab + Dummy 2) | <=100 kg Week 4 | 2.3 | 95% Confidence Interval 0.2 to 10.7 | percentage of subjects |
| Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | Arm 1 (Brodalumab + Dummy 1) | <=100 kg Week 6 | 34.1 | 95% Confidence Interval 20.5 to 48.1 | percentage of subjects |
| Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) | Arm 2 (Guselkumab + Dummy 2) | <=100 kg Week 6 | 14.0 | 95% Confidence Interval 5.6 to 26.1 | percentage of subjects |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 (Brodalumab + Dummy 1) | 56 | |
| Overall Study | STARTED | Arm 2 (Guselkumab + Dummy 2) | 57 | |
| Overall Study | COMPLETED | Arm 1 (Brodalumab + Dummy 1) | 50 | |
| Overall Study | COMPLETED | Arm 2 (Guselkumab + Dummy 2) | 50 | |
| Overall Study | NOT COMPLETED | Arm 1 (Brodalumab + Dummy 1) | 6 | |
| Overall Study | NOT COMPLETED | Arm 2 (Guselkumab + Dummy 2) | 7 |
Source ClinicalTrials.gov
Adverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Arm 1 (Brodalumab + Dummy 1) | 10 | 56 | 14 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Arm 2 (Guselkumab + Dummy 2) | 2 | 56 | 4 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Arm 1 (Brodalumab + Dummy 1) | 5 | 56 | 5 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Arm 2 (Guselkumab + Dummy 2) | 1 | 56 | 1 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Arm 1 (Brodalumab + Dummy 1) | 4 | 56 | 4 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Arm 2 (Guselkumab + Dummy 2) | 0 | 56 | 0 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Arm 1 (Brodalumab + Dummy 1) | 3 | 56 | 4 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Arm 2 (Guselkumab + Dummy 2) | 0 | 56 | 0 |
| other | COVID-19 | Infections and infestations | Arm 1 (Brodalumab + Dummy 1) | 8 | 56 | 8 |
| other | COVID-19 | Infections and infestations | Arm 2 (Guselkumab + Dummy 2) | 6 | 56 | 6 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 (Brodalumab + Dummy 1) | 0 | 56 |
| Total, all-cause mortality | Arm 2 (Guselkumab + Dummy 2) | 0 | 56 |
| Total, other adverse events | Arm 1 (Brodalumab + Dummy 1) | 37 | 56 |
| Total, other adverse events | Arm 2 (Guselkumab + Dummy 2) | 25 | 56 |
| Total, serious adverse events | Arm 1 (Brodalumab + Dummy 1) | 4 | 56 |
| Total, serious adverse events | Arm 2 (Guselkumab + Dummy 2) | 4 | 56 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38300408 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm 1 (Brodalumab + Dummy 1) vs Arm 2 (Guselkumab + Dummy 2): Occurrence of Treatment-emergent Adverse Events (AEs) From Baseline to Week 28. | Trial comparisons |
| Arm 1 (Brodalumab + Dummy 1) vs Arm 2 (Guselkumab + Dummy 2): deaths from any cause | Trial comparisons |
| Arm 1 (Brodalumab + Dummy 1) vs Arm 2 (Guselkumab + Dummy 2): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT04533737/results?page=2